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Patient-ventilator Asynchrony in Patients With Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212482
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Study Description
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Brief Summary:
Mechanical ventilation is an important support strategy for critically ill patients. It could improve gas exchange, reduce the work of breathing, and improve patient comfort. However, patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator may obfuscate these goals. Studies have shown that a high incidence of asynchrony (asynchrony index > 10%) is associated with prolonged mechanical ventilation and ICU length of stay and high mortality. So far, there have been only a few studies on the epidemiology of asynchrony in brain-injured patients. Investigators conduct a prospective observational study among brain-injured patients to determine the prevalence, risk factors and outcomes of patient-ventilator asynchrony. Esophageal pressure monitoring, a surrogate for pleural pressure, combined with airway pressure and flow waveforms is used to detect patient-ventilator asynchrony.

Condition or disease
Brain Injuries Mechanical Ventilation

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-ventilator Asynchrony in Patients With Brain Injury
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : February 29, 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The incidence of patient-ventilator asynchrony in brain-injured patients [ Time Frame: Three days ]
    The incidence of different types of patient-ventilator asynchrony in brain-injured patients.


Secondary Outcome Measures :
  1. The risk factors of patient-ventilator asynchrony in brain-injured patients [ Time Frame: Three days ]
    The risk factors of different types of patient-ventilator asynchrony in brain-injured patients


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with brain injury and receiving MV for at least 72 hours in the intensive care unit, will be enrolled in the study.
Criteria

Inclusion Criteria:

  • 1) ]older than 18 years 2) with brain injury in the ICU 3) mechanical ventilated for at least 72 hours

Exclusion Criteria:

  • 1) ICU length of stay less than 24 hours 2) enrolled in another trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212482


Locations
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China, Beijing
Jian-Xin Zhou
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Jian-Xin Zhou
Investigators
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Study Chair: Jian-Xin Zhou, MD Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jian-Xin Zhou, Doctoral Student Supervisor， chief of the department and Deputy Dean of the hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT03212482    
Other Study ID Numbers: KY 2017-028-02
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian-Xin Zhou, Capital Medical University:
brain-injured patients, patient-ventilator asychrony
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System